Home / Recalls / Alvogen, Inc / D-1082-2015

D-1082-2015 Class II Terminated

Recalled by Alvogen, Inc — Pine Brook, NJ

Recall Details

Product Type
Drugs
Report Date
May 20, 2015
Initiation Date
April 21, 2015
Termination Date
December 4, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,392 bottles (100 count)

Product Description

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01

Reason for Recall

Failed Dissolution Specification; 6 month time point

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot 457529, exp. 08/2016

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